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NCT03382964 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety and Immunogenicity of a Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers
A Phase 1 study, sponsored by Valneva Austria.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT03382964 is a Phase 1 study that has completed, run by Valneva Austria. The registered enrollment target is 120 participants.
The verdict
NCT03382964, a Phase 1 study, has completed, sponsored by Valneva Austria.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
Study Summary
Randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study investigating three dose levels of VLA1553 after a single immunization. 120 study participants will be enrolled into the study to receive three different doses (30 subjects in the low and medium and 60 subjects in the high dose group). Vaccination will be given intramuscularly on Day 0. As safety precaution, the study will begin with enrolment of 20 sentinel subjects in an open-label fashion. Thereafter, subjects will be enrolled in a blinded, randomized manner in the three study arms. A re-vaccination will be given at Month 6 or Month 12 to confirm that a single vaccination will be sufficient to induce high titer neutralizing antibodies and protect subjects from CHIKV viremia. Study participants will be followed up until 13 months after initial vaccination.
Interventions
- BIOLOGICAL VLA1553
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2018-03-05 |
| Est. Completion | 2019-07-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03382964
The ClinicalTrials.gov registry entry for NCT03382964 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Valneva Austria, which has 11 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which VLA1553 is the first listed.
NCT03382964 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03382964 about?
NCT03382964 is a clinical study titled "Study to Assess the Safety and Immunogenicity of a Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers". Randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study investigating three dose levels of VLA1553 after a single immunization. 120 study participants will be enrolled into the study to receive three different doses (30 subjects in the low and medium and 60 subjects in the...
What is the current status of trial NCT03382964?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2018-03-05. Estimated completion is 2019-07-28.
What interventions are being tested in trial NCT03382964?
The interventions under investigation include: VLA1553 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03382964?
This trial is sponsored by Valneva Austria, which has 11 total clinical trials registered on ClinicalTrials.gov.
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